| Trial ID: | L1952 |
| Source ID: | NCT03693560
|
| Associated Drug: |
Vildagliptin 50 Mg Oral Tablet
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| Title: |
Effect of Adding Vildagliptin vs Glimepiride to Metformin on Inflammation's Markers in Type-2 Diabetic Patients With CAD
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Coronary Artery Disease|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin 50 mg Oral Tablet|DRUG: Metformin 1000 mg Oral Tablet|DRUG: Glimepiride upto 4 mg Oral Tablet
|
| Outcome Measures: |
Primary: Change in markers of athero-thrombosis and inflammation ( interleukin (IL)-1 beta)., A-Change in interleukin (IL)-1 beta (IL-1ß) level will be determined by Enzyme-linked immunosorbent assay (ELISA). (unit: Picogram/milliliter pg/ml)., Baseline and 3 months|Change in High sensitivity C-reactive protein (hsCRP) level., A- High sensitivity C-reactive protein (hsCRP) level will be determined by nephelometric procedure.(unit: mg/L), Baseline and 3 months|Change in Adiponectin level., A- Adiponectin level will be determined by Enzyme-linked immunosorbent assay (ELISA)..(unit: mg/L), Baseline and 3 months | Secondary: Change in Lipid profile, A-Change inTriglycerides (TGs). (Unit : milligrams per deciliter (mg/dL)) B-Change in total cholesterol (TCH). (Unit : milligrams per deciliter (mg/dL)) C-Change in high-density lipoprotein (HDL-C). (Unit : milligrams per deciliter (mg/dL)) D-change in Low density lipoprotein cholesterol (LDL-C). (Unit : milligrams per deciliter (mg/dL)), Baseline and 3 months|Percent Change in ( Low-density lipoprotein (LDL) cholesterol / High-density lipoprotein (HDL) cholesterol ) for each patient before and after 3 months combination treatment for each group ., Percent Change in (Low-density lipoprotein (LDL) cholesterol/High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value\*100, Baseline and 3 months|Change in Hemoglobin A1c (HbA1c)., A-Change in Hemoglobin A1c (HbA1c) by ion exchange method.(Unit : percent ), Baseline and 3 months|Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) for each patient before and after 3 months combination treatment for each group ., Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value\*100, Baseline and 3 months
|
| Sponsor/Collaborators: |
Sponsor: Damanhour University | Collaborators: Tanta University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
80
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-10-08
|
| Completion Date: |
2019-10-10
|
| Results First Posted: |
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| Last Update Posted: |
2023-06-13
|
| Locations: |
Faculty of Pharmacy - Damanhour University., Damanhūr, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT03693560
|
